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Chemistry World May 22, 2007 Victoria Gill	GSK Drug's Safety Questioned A prominent US clinician has concluded that a diabetes drug produced by UK pharmaceutical company GlaxoSmithKline increases the risks of heart attack and death.
The Motley Fool June 12, 2007 Michael P. Cecil	When Dr. Nissen Talks ... Congress and the FDA listen. The Avandia story is just beginning, and drug-safety issues were hard on the share prices of Merck when Vioxx was in the news, as well as Pfizer when torcetrapib was taken off the market.
Chemistry World September 24, 2010 Andrew Turley	End of the road for Avandia? The European Medicines Agency has decided the troubled diabetes drug should be pulled from the market while the US Food and Drug Administration has said it will 'significantly restrict' its use.
Chemistry World July 16, 2010 Matt Wilkinson	Bittersweet victory for GSK's Avandia GlaxoSmithKline has received a muted 'thumbs up' from a US regulatory advisory panel for its much-maligned Type 2 diabetes drug Avandia (rosiglitazone), making it likely the US Food and Drug Administration will allow the UK-based pharma giant to continue selling the drug in the US.
Chemistry World July 31, 2007 Victoria Gill	FDA Advised: Avandia Should Stay on the Market The US Food and Drug Administration's (FDA's) Advisory Committee came to an almost unanimous decision yesterday for Avandia, GlaxoSmithKline's much-maligned diabetes treatment, to remain on the US market.
The Motley Fool May 22, 2007 Mike Havrilla	Avandia Safety Concerns Weigh Down Glaxo Shares of GlaxoSmithKline dropped nearly 8%, after a study raised safety concerns about the company's widely used diabetes drug, Avandia.
Pharmaceutical Executive July 3, 2007 Walter Armstrong	Back Page: Oh Man, Avandia Think you know the Avandia story? Pharma execs should take this test to see what they missed.
BusinessWeek February 28, 2005 Capell & Carey	A Drug Watchdog To Rival The FDA Europe's agency will soon have new powers. Will it take the lead on safety?
Pharmaceutical Executive January 1, 2006 Kenneth I. Kaitin	Opinion: Memo to von Eschenbach FDA's acting commissioner has an opportunity to clarify a lot of misconceptions about the agency's role in regulating drug safety. His first order of business should be to explain exactly what FDA doesn't do.
Pharmaceutical Executive March 1, 2007 Jill Wechsler	Washington Report: Safety First FDA seeks to regain public trust by making drug-safety information more transparent - and to head off more stringent legislation in the process.
Pharmaceutical Executive April 1, 2007 Patrick Clinton	From the Editor: Taking It Outside FDA Commissioner Andy von Eschenbach said something pretty reasonable, and in return received a blistering, menacing letter from Senator Charles Grassley -- a letter that showed yet again that Grassley just doesn't understand what he's destroying in his campaign against FDA.
CIO March 15, 2006 Allan Holmes	Rx for Risk As it revamps its workflow processes, the FDA is relying on technology to reduce the risk that unsafe substances will get into the market.
Chemistry World February 26, 2010 Sarah Houlton	Report hits out at GSK's Avandia GlaxoSmithKline's diabetes drug Avandia (rosiglitazone) has been dealt another blow, with the publication of a report by two US senators claiming the company knew about safety problems long before they reached the public domain.
The Motley Fool April 10, 2008 Brian Lawler	Glaxo Angers the FDA GlaxoSmithKline announces that the FDA has sent it a warning letter regarding its failure to meet certain post-marketing requirements for Avandia.
The Motley Fool July 30, 2007 Brian Lawler	Is Glaxo's Avandia Down for the Count? An FDA advisory committee is set to debate one of Glaxo's top compounds. What will it mean to investors?
The Motley Fool December 31, 2010 Brian Orelli	2010 FDA Approvals and a Look Ahead Recent history can help us handicap FDA decisions.
The Motley Fool July 8, 2008 Brian Lawler	Blockbuster Drugs Bound for Extinction? One of the biggest classes of prescription drugs, those for diabetes treatments, faces tougher FDA standards.
Pharmaceutical Executive March 1, 2012 Ron Cohen	FDA's Necessary Dose of Reality There's no fast-acting salve, but there are several steps that can be taken to streamline many of the procedures at FDA. And it begins with leadership.
The Motley Fool March 15, 2010 Brian Orelli	FDA Says "No Way!" Market Says "Yeah, Baby!" You can have it both ways. The Food and Drug Administration's response wasn't exactly what investors in Amylin Pharmaceuticals, Eli Lilly, and Alkermes were looking for, but they'll take it.
The Motley Fool February 22, 2010 Brian Orelli	Warning: Avandia Could Cause Drool Among Trial Lawyers An unintended side effect of Glaxo's Avandia might be excessive salivation among trial lawyers. A 342-page report by the Senate Finance Committee is painting the diabetes drug in a not-so-great light.
The Motley Fool September 16, 2008 Brian Lawler	Pfizer Puts Safety First Increased FDA scrutiny may motivate the pharmaceutical's new drug-safety site.
Pharmaceutical Executive January 1, 2007 Jill Wechsler	Washington Report: A Full Plate It's going to be a busy year in Washington for the pharmaceutical industry. Drug safety, unapproved uses, e-data requirements, and a shift to personalized medicine are just a few of the hot issues on tap for 2007.
Pharmaceutical Executive January 1, 2007	Thoughtleader: Peter Pitts. DrugWonks.com Here, the chief voice of a blog hosted by the non-profit Center for Medicine in the Public Interest urges pharma to continuously plug its positions and get politics out of science, and offers some perspective on important regulatory reforms facing the FDA.
The Motley Fool June 14, 2007 Brian Lawler	Dueling Fools: GlaxoSmithKline Bull Shares of the pharmaceutical may be temporarily down, but it's not out.
Pharmaceutical Executive June 1, 2007 Patrick Clinton	From the Editor: Not His Problem In the current climate, who's going to get doctors to take on the work of making good decisions and occasionally the responsibility for having made a bad one?
The Motley Fool April 26, 2011 Luke Timmerman	FDA Says Vertex Drug a Wee Bit More Effective Than Advertised; Stock Climbs Good news for Vertex?
Pharmaceutical Executive January 1, 2009 Jill Wechsler	FDA Turnaround Time Will more resources and new leadership fix FDA, or is a major overhaul in order?
The Motley Fool February 1, 2011 Brian Orelli	Orexigen Falls Short Its obesity drug fails in the final mile of the drug-development marathon.
Pharmaceutical Executive July 3, 2007 Louis A. Morris	Culture Shock The withdrawal of Vioxx signaled a sea change. Welcome to the Culture of Drug Safety. The FDA is making changes in the way it reviews drug safety. Post-marketing staff has been enlarged 25%, and new, tougher laws are on the way.
The Motley Fool August 22, 2007 Brian Orelli	Regulating the Drug Pushers The FDA might get a little tougher on drug ads, following a report that they may not be watching advertisers claims closely enough, or warning patients about side effects strongly enough.
Pharmaceutical Executive January 1, 2011 Jill Wechsler	Politics & PDUFA Pharma companies will assess health reform, negotiate user fees and keep an eye on federal prosecutors in the year ahead.
The Motley Fool February 16, 2010 Brian Orelli	For Blockbuster Cancer Drugs, Approvals Are the Easy Part Don't get too excited. As an investor, you can lower your risk by investing in cancer drug companies after a clinical trial success but before an FDA approval, but you'll also reduce your reward.
Pharmaceutical Executive February 1, 2011 Jill Wechsler	Challenges, Changes, Commitments The Three Cs could be taxing on FDA resources as the new Congress brings stiffer oversight and leadership revisions to the agency
Pharmaceutical Executive September 1, 2005 Jill Wechsler	Washington Report: Crawford Steps Up As FDA's new commissioner takes the reins, his key challenge is restoring trust in the agency.
Managed Care July 2005 Martin Sipkoff	Support Grows for Establishing National Clinical Trial Registry Stakeholders are pushing for a national clinical trial registry, and efforts by UnitedHealth Group are in the forefront. Medical journals are setting hard and fast rules.
Chemistry World December 2, 2013 Lanay Tierney	US turnaround on Avandia restrictions Restrictions on the controversial diabetes medication Avandia (rosiglitazone) are to be lifted by the US Food and Drug Administration.
The Motley Fool October 18, 2006 Brian Lawler	Another Hard Pill to Swallow A former FDA chief will take the fall for not disclosing holdings, but the pharmaceuticals industry needs more than that.
The Motley Fool July 31, 2007 Brian Lawler	Avandia Can Stay An FDA advisory panel votes to allow GlaxoSmithKline's top diabetes compound, Avandia, to remain on the market.
The Motley Fool August 17, 2007 Brian Orelli	Fewer Drug Approvals? Buy! Stricter standards at the FDA could create a buying opportunity. Drug approvals are down one third this year, creating a lot of value in pharmaceutical and biotech companies. Just choose your medicines carefully.
The Motley Fool September 18, 2007 Brian Orelli	PDUFA Reauthorization: Almost There Much to the applause of drug makers and those who invest in them, the Prescription Drug User Fee Act reauthorization looks like it could come out of a Congressional conference committee as early as this week.
The Motley Fool December 2, 2010 Brian Orelli	A Short FDA Delay. For What? GlaxoSmithKline and Valeant aren't saying.
Pharmaceutical Executive April 1, 2006 Jill Wechsler	Washington Report: A Warning Trend Washington's new answer to drug safety concerns is more warnings and more disclosure of undigested data. But warnings can go too far. Haven't FDA's critics ever heard the story of the boy who cried wolf?
Pharmaceutical Executive July 30, 2007 Richard Altus	Avandia Sales Away What did you do when you heard the safety news about Avandia? Here's what the rest of the market did, and why it matters to you.
The Motley Fool July 15, 2010 Brian Orelli	The Blockbuster Drug Survives Another Body Blow Avandia is still standing.
The Motley Fool June 3, 2011 Brian Orelli	FDA Bullies Obesity Drugmakers It's been clear for some time that the Food and Drug Administration isn't particularly fond of obesity drugs. Now it's just being a bully.
The Motley Fool March 31, 2008 Brian Lawler	FDA Commish Joins Blogosphere Andrew von Eschenbach, the FDA's chief, starts a weekly blog.
The Motley Fool March 5, 2008 Brian Orelli	FDA (Indirectly) Thwacks Amylin The FDA's draft guidance puts a cloud of uncertainty over the makers of diabetes drugs.
The Motley Fool March 7, 2005 Brian Gorman	Glaxo in Hot Water Glaxo's problems with the FDA could have been avoided. Investors can only hope that the FDA is in a forgiving mood.
The Motley Fool September 14, 2010 Luke Timmerman	Arena Obesity Drug Effective by "Slim Margin"; Shares Tumble The market is reacting negatively to news about the company's weight-loss drug.
Pharmaceutical Executive March 1, 2006 Jill Wechsler	Washington Report: Labels and Liability New FDA guidance aims at better communication of risks. But it creates some, too.